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    Clinical Trial Results:
    Essai randomisé de phase II/III évaluant une stratégie thérapeutique post-opératoire individualisée chez les patients opérés d’un carcinome bronchique non à petites cellules (CBNPC) non épidermoïde de stade II – IIIA non N2.

    Summary
    EudraCT number
    		 2008-004939-38
    Trial protocol
    		 FR  
    Global end of trial date
    31 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Dec 2022
    First version publication date
    31 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFCT-0801 TASTE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00775385
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IFCT
    Sponsor organisation address
    10 rue de la Grange Batelière , Paris, France, 750009
    Public contact
    Contact, IFCT, +33 1 56 81 10 45, contact@ifct.fr
    Scientific contact
    Contact, IFCT, +33 1 56 81 10 45, contact@ifct.fr
    Sponsor organisation name
    IFCT
    Sponsor organisation address
    10 rue de la Grange Batelière , Paris, France, 750009
    Public contact
    Contact, IFCT, +33 1 56 81 10 45, contact@ifct.fr
    Scientific contact
    Contact, IFCT, +33 1 56 81 10 45, contact@ifct.fr
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Faisabilité : Pourcentage de patients randomisés ayant, dans un délai de 8 semaines (soit J56) suivant la chirurgie, débuté le traitement après rendu du résultat de l’analyse des biomarqueurs (mutation EGFR et expression d’excision repair cross complementing-1 ou ERCC1).
    Protection of trial subjects
    Algorithms for management of adverse events were provided in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 152
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    101
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From May 2009 to July 2012, 29 centers across France recruited a total of 150 patients with completely resected non-squamous stage II or IIIA non-N2 tumors

    Pre-assignment
    Screening details
    		 Chemotherapy-naive patients with histologically confirmed and surgically resected stage II or IIIA non-N2 non-squamous NSCLC were eligible, with study inclusion occurring between D2 and D42 postsurgery to be able to deliver biomarker analysis before day 56, then perform random assignment, and then finally start therapy (or follow-up) before D61.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 Standard chemotherapy with cisplatin and pemetrexed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four cycles of cisplatin 75 mg/m² every 21 days

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four cycle of pemetrexed 500 mg/m² every 21 days

    Arm title
    		 Arm B
    Arm description
    		 For patient presenting activating EGFR mutations were treated with oral erlotinib at 150 mg per day for 1 year. In the absence of EGFR mutations, ERCC1 expression levels were taken into account : - Patients with negative ERCC1 status were administered cisplatin plus pemetrexed. - Patients with positive ERCC1 status underwent exclusively follow-up.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Erlotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Erlotinib at 150 mg per day for 1 year.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four cycles of cisplatin 75 mg/m² every 21 days

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Four cycle of pemetrexed 500 mg/m² every 21 days

    Number of subjects in period 1 [1]
    		Arm A Arm B
    Started
    74
    76
    Completed
    71
    74
    Not completed
    3
    2
         Did not received treatment
    3
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 2 withdrawals of consent.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Standard chemotherapy with cisplatin and pemetrexed.

    Reporting group title
    Arm B
    Reporting group description
    		 For patient presenting activating EGFR mutations were treated with oral erlotinib at 150 mg per day for 1 year. In the absence of EGFR mutations, ERCC1 expression levels were taken into account : - Patients with negative ERCC1 status were administered cisplatin plus pemetrexed. - Patients with positive ERCC1 status underwent exclusively follow-up.

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 74 76 150
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 60 (36 to 75) 59 (34 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 29 30 59
        Male
    		 45 46 91
    Pathologic stage
    Units: Subjects
        IIA
    		 34 35 69
        IIB
    		 25 23 48
        IIIA
    		 14 18 32
        IV
    		 1 0 1
    Histologic subtype
    Units: Subjects
        Adenocarcinoma
    		 60 65 125
        Other non-squamous
    		 14 11 25
    History of smoking
    Units: Subjects
        Yes
    		 67 70 137
        No
    		 7 6 13
    ECOG PS
    Units: Subjects
        PS 0
    		 47 42 89
        PS 1
    		 27 34 61
    BMI
    Units: Subjects
        <=20
    		 10 14 24
        ]20-26[
    		 43 47 90
        [26-30[
    		 14 10 24
        >30
    		 7 5 12
    Weight loss in the 3 months before inclusion
    Units: Subjects
        ≤ 10%
    		 66 69 135
        > 10%
    		 8 7 15
    Number of pack-year
    Units: Pack-year
        median (full range (min-max))
    		 39 (2 to 100) 38 (0 to 165) -

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 Standard chemotherapy with cisplatin and pemetrexed.

    Reporting group title
    Arm B
    Reporting group description
    		 For patient presenting activating EGFR mutations were treated with oral erlotinib at 150 mg per day for 1 year. In the absence of EGFR mutations, ERCC1 expression levels were taken into account : - Patients with negative ERCC1 status were administered cisplatin plus pemetrexed. - Patients with positive ERCC1 status underwent exclusively follow-up.

    Primary: Patients who started their treatment within 2 months of surgery

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    End point title
    		 Patients who started their treatment within 2 months of surgery
    End point description
    Patients who started their treatment within 2 months of surgery, with available biomarker information.
    End point type
    Primary
    End point timeframe
    Day 61
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    76
    Units: % of success
        number (confidence interval 95%)
    77 (69.0 to 85.1)
    83 (75.8 to 90.0)
    Statistical analysis title
    		 Overall success rate
    Comparison groups
    Arm A v Arm B
    Number of subjects included in analysis
    150
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.05
    Method
    		 bionomial test
    Parameter type
    		 Difference Between Proportions
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Notes
    [1] - Fleming single-stage

    Secondary: Cisplatin - Pemetrexed exposure

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    End point title
    		 Cisplatin - Pemetrexed exposure
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 1 year
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    53 [2]
    Units: Number of participants
        Cycle 1
    71
    51
        Cycle 2
    69
    47
        Cycle 3
    68
    45
        Cycle 4
    61
    43
    Notes
    [2] - 53 patients with negative ERCC1 status
    No statistical analyses for this end point

    Secondary: Erlotinib exposure

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    End point title
    		 Erlotinib exposure [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 1 year
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is only applicable for Arm B patients with EGFR mutations who received Erlotinib.
    End point values
    		 Arm B
    Number of subjects analysed
    7 [4]
    Units: days
        median (full range (min-max))
    344 (10 to 367)
    Notes
    [4] - 7 patients with EGFR mutations
    No statistical analyses for this end point

    Secondary: Theoretical dose of cisplatin received

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    End point title
    		 Theoretical dose of cisplatin received
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 4 cycles
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    53 [5]
    Units: Pourcentage of theoretical dose
    median (full range (min-max))
        Cycle 1
    99.5 (86 to 111.4)
    99.7 (81.6 to 104.4)
        Cycle 2
    99.5 (75.1 to 108)
    99.5 (83.5 to 104.4)
        Cycle 3
    99.3 (47 to 111.6)
    99.16 (67.2 to 104.8)
        Cycle 4
    99.0 (84.9 to 106.2)
    99.2 (48.5 to 103.5)
    Notes
    [5] - 53 patients with negative ERCC1 status
    No statistical analyses for this end point

    Secondary: Theoretical dose of pemetrexed received

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    End point title
    		 Theoretical dose of pemetrexed received
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 4 cycles
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    53 [6]
    Units: Pourcentage of theoretical dose
    median (full range (min-max))
        Cycle 1
    99.6 (86 to 106.3)
    99.9 (81.6 to 103.1)
        Cycle 2
    99.6 (75.9 to 104.2)
    99.9 (83.5 to 103)
        Cycle 3
    99.5 (76.2 to 107.6)
    99.6 (66.9 to 107.9)
        Cycle 4
    99.5 (84.9 to 104.6)
    99.2 (67.2 to 102.5)
    Notes
    [6] - 53 patients with negative ERCC1 status
    No statistical analyses for this end point

    Post-hoc: EGFR Mutation and ERCC1 Expression Status

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    End point title
    		 EGFR Mutation and ERCC1 Expression Status
    End point description
    Results pertaining to EGFR mutation status and ERCC1 expression levels in the two treatment arms.
    End point type
    Post-hoc
    End point timeframe
    61 days
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    76
    Units: Number of participants
        EGFR mutated, ERCC1 nonexpressed
    0
    5
        EGFR mutated, ERCC1 positive
    2
    2
        EGFR mutated, ERCC1 undetermined
    1
    0
        EGFR nonmutated, ERCC1 nonexpressed
    39
    41
        EGFR nonmutated, ERCC1 positive
    16
    17
        EGFR nonmutated, ERCC1 undetermined
    10
    8
        EGFR undetermined, ERCC1 nonexpressed
    2
    2
        EGFR undetermined, ERCC1 positive
    1
    0
        EGFR undetermined, ERCC1 undetermined
    3
    1
    No statistical analyses for this end point

    Post-hoc: EGFR Mutation

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    End point title
    		 EGFR Mutation
    End point description
    End point type
    Post-hoc
    End point timeframe
    61 days
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    76
    Units: Number of participants
        Mutated
    3
    7
        Nonmutated
    65
    66
        Undetermined
    6
    3
    No statistical analyses for this end point

    Post-hoc: ERCC1 Expression Status

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    End point title
    		 ERCC1 Expression Status
    End point description
    End point type
    Post-hoc
    End point timeframe
    61 days
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    74
    76
    Units: Number of participants
        Nonexpressed
    41
    49
        Positive
    19
    19
        Undetermined
    14
    8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected for a patient from the date of signature of inform consent form, during treatment period and until 30 days after the last dose of study treatment. Deaths were collected until data analysis.
    Adverse event reporting additional description
    The maximal grade of adverse events was collected by cycle of treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 145 (17.24%)
         number of deaths (all causes)
    30
         number of deaths resulting from adverse events
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reduced general condition
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial fistula
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumopathy
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Psychosis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Creatinine increased
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypokalemia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Intracranial hemorrhage
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Hemoglobin decreased
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutrophils count increased
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 145 (2.07%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Anorexia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Diarrhea
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 145 (1.38%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Injection site reaction
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute renal failure
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 145 (2.07%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Localized infection
         subjects affected / exposed
    1 / 145 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    141 / 145 (97.24%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    99 / 145 (68.28%)
         occurrences all number
    261
    Weight loss
         subjects affected / exposed
    9 / 145 (6.21%)
         occurrences all number
    13
    Chest pain
         subjects affected / exposed
    46 / 145 (31.72%)
         occurrences all number
    102
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    7 / 145 (4.83%)
         occurrences all number
    11
    Cough
         subjects affected / exposed
    30 / 145 (20.69%)
         occurrences all number
    70
    Dyspnoea
         subjects affected / exposed
    62 / 145 (42.76%)
         occurrences all number
    154
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    10 / 145 (6.90%)
         occurrences all number
    14
    Investigations
    Creatine increased
         subjects affected / exposed
    13 / 145 (8.97%)
         occurrences all number
    23
    Nervous system disorders
    Neuropathy
         subjects affected / exposed
    9 / 145 (6.21%)
         occurrences all number
    9
    Paresthesia
         subjects affected / exposed
    14 / 145 (9.66%)
         occurrences all number
    25
    Headache
         subjects affected / exposed
    15 / 145 (10.34%)
         occurrences all number
    27
    Blood and lymphatic system disorders
    Haemoglobin decreased
         subjects affected / exposed
    88 / 145 (60.69%)
         occurrences all number
    269
    Neutrophil count decreased
         subjects affected / exposed
    87 / 145 (60.00%)
         occurrences all number
    226
    Platelet count decreased
         subjects affected / exposed
    36 / 145 (24.83%)
         occurrences all number
    83
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    14 / 145 (9.66%)
         occurrences all number
    27
    Eye disorders
    Eyes tearing
         subjects affected / exposed
    9 / 145 (6.21%)
         occurrences all number
    19
    Gastrointestinal disorders
    Anorexia
         subjects affected / exposed
    38 / 145 (26.21%)
         occurrences all number
    70
    Constipation
         subjects affected / exposed
    29 / 145 (20.00%)
         occurrences all number
    37
    Diarrhoea
         subjects affected / exposed
    26 / 145 (17.93%)
         occurrences all number
    50
    Dysgeusia
         subjects affected / exposed
    10 / 145 (6.90%)
         occurrences all number
    19
    Nausea
         subjects affected / exposed
    100 / 145 (68.97%)
         occurrences all number
    256
    Oral mucosal irritation
         subjects affected / exposed
    24 / 145 (16.55%)
         occurrences all number
    29
    Vomiting
         subjects affected / exposed
    42 / 145 (28.97%)
         occurrences all number
    66
    Abdominal pain
         subjects affected / exposed
    10 / 145 (6.90%)
         occurrences all number
    11
    Gastralgia
         subjects affected / exposed
    9 / 145 (6.21%)
         occurrences all number
    14
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    11 / 145 (7.59%)
         occurrences all number
    29
    Erythema
         subjects affected / exposed
    7 / 145 (4.83%)
         occurrences all number
    8
    Rash
         subjects affected / exposed
    12 / 145 (8.28%)
         occurrences all number
    35
    Scar pain
         subjects affected / exposed
    11 / 145 (7.59%)
         occurrences all number
    27
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    17 / 145 (11.72%)
         occurrences all number
    39
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    14 / 145 (9.66%)
         occurrences all number
    24
    Joint pain
         subjects affected / exposed
    10 / 145 (6.90%)
         occurrences all number
    11
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    16 / 145 (11.03%)
         occurrences all number
    18
    Conjunctivitis
         subjects affected / exposed
    15 / 145 (10.34%)
         occurrences all number
    28
    Rhinitis
         subjects affected / exposed
    9 / 145 (6.21%)
         occurrences all number
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 May 2009
    A first modification of the protocol was done in order to: - Add new sites - Remove a scanner done prior inclusion of the patient - Clarify the follow-up of the patients - Complete the adverse events list of erlotinib
    26 Apr 2011
    A 2nd modification was done after the analysis of the first 108 patients. The steering committee of the study decided to extend the study to 56 additional patients because the frequency of EGFR mutations and ERCC1 over-expressions was not the expected frequencies. Fifty-six additional patients were necessary to verify the phase III hypothesis for the number of patients.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The Phase III part was cancelled due to the unreliability of the ERCC1 IHC read-outs.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24638013
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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